Efficacy of Nalmefene in Patients With Alcohol Dependence (ESENSE2)

Lundbeck

Status and phase

Completed

Phase 3

Conditions

Alcohol Dependence

Treatments

Drug: Placebo

Drug: Nalmefene

Study type

Interventional

Funder types

Industry

Identifiers

NCT00812461

12023A

2007-002563-27 (EudraCT Number)

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.

Full description

Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by at least three of a number of criteria such as tolerance, withdrawal symptoms, frequent use of alcohol in larger amounts or over longer periods than was intended, and others. Excessive intake of alcohol reduces the life span by a decade, and alcohol drinking is strongly related to mortality from liver cirrhosis, chronic pancreatitis, certain cancers, hypertension, accidents and violence. This study is planned to evaluate the efficacy and safety of as needed use of nalmefene 18.06 mg versus placebo in decreasing monthly Heavy Drinking Days (HDDs) and decreasing the total consumption during a period of 24 weeks in adult patients with alcohol dependence.

Enrollment

678 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

In- and outpatients who:

had a primary diagnosis of alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - text revision (DSM-IV-TR) criteria
had had ≥6 HDDs in the 4 weeks preceding the Screening Visit
had had an average alcohol consumption at WHO medium risk level or above in the 4 weeks preceding the Screening Visit

Exclusion criteria

The patient:

had a DSM-IV Axis I disorder other than alcohol dependence or nicotine dependence
had an antisocial personality disorder
had risk of suicide evaluated by the suicidality module of the Mini-International Neuropsychiatric Interview (MINI)
had a history of delirium tremens or alcohol withdrawal seizures
reported current or recent (within 3 months preceding screening) treatment with disulfiram, acamprosate, topiramate, naltrexone or carbimide, or with any opioid antagonists
reported current or recent treatment with antipsychotics or antidepressants
was pregnant or breast-feeding

Other protocol-defined inclusion and exclusion criteria may apply.